Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

HBE 2021-04-11

Velocity Alpha Highspeed Surgical Drill System

Applicant Adeor Medical AG

K-Number K191479

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FXX 2021-04-11

Surgical Mask

Applicant Customfab, Inc.

K-Number K203012

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FXX 2021-04-11

Medical Surgical Mask (Non-sterile)

Applicant Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.

K-Number K202761

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FXX 2021-04-09

Disposable Medical Face Mask-Model FM-04

Applicant Shenzhen Jinko Industrial Co., Ltd.

K-Number K202513

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LLZ 2021-04-09

DeepLook PRECISE

Applicant Deeplook, Inc.

K-Number K202084

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JKA 2021-04-09

EasyPoint Blood Collection Plus

Applicant Retractable Technologies, Inc.

K-Number K202325

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QNP 2021-04-09

GI Genius

Applicant Cosmo Artificial Intelligence - Ai, Ltd.

K-Number DEN200055

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OVD 2021-04-09

IdentiTi ALIF Standalone Interbody System

Applicant Alphatec Spine, Inc.

K-Number K203742

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FDT 2021-04-09

PENTAX Medical Video Duedenoscope ED34-i10T2

Applicant Pentax of America, Inc.

K-Number K210710

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IYN 2021-04-09

HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K210068

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HBC 2021-04-09

hekaDrill

Applicant Zethon, Ltd.

K-Number K193630

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HQD 2021-04-09

Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K203571

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